NSK VarioSurg Manual Del Operador página 24

Guidance and manufacturer's declaration - electromagnetic emissions
The VarioSurg is intended for use in the electromagnetic environment specified below. The customer or the user of the VarioSurg should assure that is used in such an environment.
Emissions test
RF emissions
CISPR11/EN55011
RF emissions
CISPR11/EN55011
Harmonic emissions EN/IEC61000-3-2
Voltage fluctuations/ flicker emissions
EN/IEC61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
The VarioSurg is intended for use in the electromagnetic environment specified below. The customer or the user of the VarioSurg should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
EN/IEC61000-4-2
Electrical fast transient/burst
EN/IEC61000-4-4
Surge
EN/IEC61000-4-5
Voltage dips, short interruptions and
voltage variations on power supply input
lines
EN/IEC61000-4-11
Power frequency (50/60Hz)
magnetic field
EN/IEC61000-4-8
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer's declaration - electromagnetic immunity
The VarioSurg is intended for use in the electromagnetic environment specified below. The customer or the user of the VarioSurg should assure that it is used in such an environment.
Immunity test EN/IEC60601 test level
Conducted RF EN/IEC61000-4-6 3Vrms150 kHz to 80MHz
Radiated RF EN/IEC61000-4-3 3V/m80MHz to 2.5 GHz
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobiles radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the VarioSurg is used exceeds the applicable RF compliance level above, the VarioSurg should be observed to
verity normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the VarioSurg.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
Compliance Electromagnetic environment - guidance
Group 1 The VarioSurg uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
class B The VarioSurg is suitable for use in all establishments other than domestic, and may be used in domestic establishments
and those directly connected to public low-voltage power supply network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
class A
Complies
Warning: VarioSurg is intended for use by healthcare professionals only. VarioSurg may cause radio interference or may
disrupt the operation of nearby equipment.
It may be necessary to take mitigation measures such as re-orienting or relocating the VarioSurg or shielding the location.
EN/IEC60601 test level Compliance level
±6kV contact ±6kV contact
±8kV air ±8kV air
±2kV for power supply lines ±2kV for power supply lines
±1kV for input/output ±1kV for input/output
±1kV line to line ±1kV line to line
±2kV lines to earth ±2kV lines to earth
<5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut)
for 0.5 cycle for 0.5 cycle
40% Ut (60% dip in Ut) 40% Ut (60% dip in Ut)
for 5 cycles for 5 cycles
70% Ut (30% dip in Ut) 70% Ut (30% dip in Ut)
for 25 cycles for 25 cycles
<5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut)
for 5 sec for 5 sec
3 A/m 3 A/m
Compliance level
3 Vrms
3 V/m
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%.
Mains power quality should be that of a typical commercial or
hospital environment.
Mains power quality should be that of a typical commercial or
hospital environment.
Mains power quality should be that of a typical commercial
or hospital environment. If the user of the VarioSurg requires
continued operation during power mains interruptions, it
is recommended that the VarioSurg be powered from an
uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used
no closer to any part of the VarioSurg, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 P
d = 1.2 P 80MHz to 800MHz
d = 2.3 P 800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters as determined by an
electromagnetic site survey, should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
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